Field safety notices - 30 to 03 April 2015

List of field safety notices (FSNs) from medical device manufacturers from 30 to 3 April 2015.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

AcuFocus: KAMRA corneal inlay

March 2015

Device description: implants, non active, intraocular

Model: ACI 7000

MHRA reference: 2015/003/027/701/001

ArcRoyal: Terumo two part syringe

20 March 2015

Device description: injection devices

MHRA reference: 2015/003/031/701/003

BTE Technologies: Primus

19 March 2015

Device description: diagnostic measurement and monitoring

Model: PrimusRS (PRRS)

MHRA reference: 2015/003/027/701/006

GE Healthcare: Millennium VG, Discovery VH, VariCam

FMI 40865

Device description: gamma camera

Model: Millennium VG, Discovery VH, VariCam (all configurations)

MHRA reference: 2015/003/026/071/004

Johnson & Johnson Medical: Omrix pressure regulators

13 March 2015

Device description: surgical devices, non-powered

MHRA reference: 2015/003/026/071/009

Life Technologies Corporation: A*02 SSP UniTray, Allset Gold Plus SSP and A High Res SSP UniTray, Allset Gold Plus SSP

16 March 2015

Device description: IVDs, immunology

MHRA reference: 2015/003/031/601/008

Philips Healthcare : ADAC Vertex Plus, CARDIO and Solus ADAC V60 ADAC C60

12 February 2015

Device description: nuclear medicine, gamma camera systems & accessories

Model: Manual Collimator Exchange system in use with an ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 imaging system - 88297: ADAC Vertex Plus, CARDIO and Solus 882380: ADAC V60 882040: ADAC C60

MHRA reference: 2015/004/001/071/007

Prism Medical: Freeway M150

16 March 2015

Device description: hoists and slings

MHRA reference: 2015/002/025/081/024

Siemens Healthcare Diagnostics: ADVIA chemistry lipase reagent

March 2015

Device description: IVDs, clinical chemistry

MHRA reference: 2015/003/027/601/003

Siemens Healthcare Diagnostics: ADVIA Centaur XPT

March 2015 (CSW 15-02)

Device description: IVDs, clinical chemistry

MHRA reference: 2015/004/001/601/002

Siemens: Artis Q, Artis Q.zen

06 March 2015

Device description: X-ray, fluoroscopy systems

MHRA reference: 2015/003/026/601/003

Siemens: AXIOM Aristos FX

UI XP090/14/S and UI XP091/14/S

Device description: X-ray, general

Model: 7414803

MHRA reference: 2015/003/026/601/012.

Terumo: Terumo Radifocus Optitorque Catheter

04 /2015

Device description: vascular cannula and catheters

Product code: RH-5TIG110M

MHRA reference: 2015/004/001/071/010

Thermo Fisher: oxoid antimicrobial testing disc CN10

27 March 2015

Device description: IVDs, bacteriology

Model: CT0024B CN10 Gentamicin

MHRA reference: 2015/003/030/601/003

Thermo Fisher Scientific: oxoid modified tryptone soya broth

31 March 2015

Device description: IVDs, bacteriology

Model: CM0989B

MHRA reference: 2015/003/031/601/007

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